UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Resveratrol derivative-rich melinjo seed extract in the treatment of chronic periodontitis patients A randomized controlled pilot study
Title of the study (Brief title)	Resveratrol in the treatment of periodontitis patients
Region	Japan

Condition
Condition	Periodontitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to assess the effect of melinjo seed extract on patients who had been treated previously for periodontitis and were in supportive periodontal therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The following clinical parameters were recorded at each visit (baseline, week4, week8): (1) pocket depth(PD); (2) clinical attachment level (CAL); (3) bleeding on probing (BOP)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Patients received 150mg of melinjo seed extract for 8 weeks.
Interventions/Control_2	Patients received 150mg of placebo for 8 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) no use of systemic antibiotics or oral anti-microbial agents within the past six months; (2) periodontitis defined as the presence (on fully erupted teeth) of at least one site with a probing depth (PD) 5-7 mm;
Key exclusion criteria	(1)severe systemic disease; (2) pregnancy.
Target sample size	18

Research contact person
Name of lead principal investigator	Yuichi Izumi
Organization	Tokyo Medical and Dental University
Division name	Department of Periodontology
Address	Yushima 1-5-45 Bunkyo tokyo JAPAN
TEL	03-5803-5488
Email	y-izumi.peri@tmd.ac.jp

Public contact
Name of contact person	Yuichi Ikeda
Organization	Tokyo Medical and Dental University
Division name	Department of Periodontology
Address	Yushima 1-5-45 Bunkyo tokyo JAPAN
TEL	03-5803-5488
Homepage URL
Email	ikeda.peri@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	1286
Org. issuing International ID_1	Tokyo Medical and Dental University Institutional Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	Tokyo Medical and Dental University

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 01 Month 14 Day
Last modified on	2019 Year 01 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040494